MHRA-100046-PIP01-21-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • cenobamate
Invented Name
  • Xcopri
PIP Number MHRA-100046-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet, Tablet, Oral suspension, Solution for injection
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of epilepsy
Route(s) of administration
  • Oral use
  • Parenteral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance opinion date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):cenobamate.pdf
Published Date 03/11/2021